Pharmaceutical / Biotechnical: Commercialization Phase

Learn How MasterControl Help Enterprises in Pharmaceutical / Biotechnical Commercialization Phase in Order to Support Cross Functional Teams

Companies ramp up for the expected product approval during the commercialization phase of drug development. The manufacturing team completes line build-outs, in addition to process validations. Based on marketing sales forecasts, the manufacturing team also develops long-term purchasing plans. Training operators on new processes and equipment is another important function. Software for managing the training process helps ensure FDA compliance, which requires verification of training.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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White Paper:

Five Pharma Trends that Will Have the Biggest Impact in 2017
Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
How Software Helps Pharma/Biotech Maximize Value of External Resources

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)

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MasterControl Quality Management System (QMS) Overview

As full-scale production gets underway, the quality assurance team implements the quality plan and begins playing an active role in making sure that all components, raw materials, and finished goods are in compliance with drug specifications. The quality team also investigates nonconformance issues, CAPAs, etc. MasterControl reporting and analytics software can help in this area, too, as can MasterControl process automation software, which automates the management of deviations, nonconformances, CAPAs, product changes, and supplier audits.

Biotechnical Commercialization Phase Software Solutions

MasterControl Documents

MasterControl Collaboration

MasterControl Training

Other MasterControl Automation Processes

Controlled Documents Managed in the Commercialization Phase

Collaboration Workflows in the Commercialization Phase

Nonconformances

CAPAs

Validation testing protocols and reports

Clinical Trial Master File (CTMF)

Potential global submissions

Labeling and promotional materials

FDA correspondence

Quality plan

SOPs

Packaging and distribution plans

Long-term purchasing plans

Training records

Product sample plans

Market research and strategic plans

Product Launch plans: The product launch is developed and executed by the sales and marketing team, but requires the involvement of other departments as well. Discovery and development provide input on sales training documents, which require their scientific knowledge and understanding of the clinical data, while the regulatory and legal departments review and sign off on all launch plans.

Manufacturing and distribution: As the company builds out manufacturing for the product launch, decisions that drive expenditures, such as supply, capacity, and product shelf life, depend on collaboration between sales and marketing, manufacturing, and finance.

Commercial Materials: Product packaging, in both sample and stock bottles, UPC labeling, and package inserts must be circulated, reviewed, and approved by the marketing, regulatory, and management teams.

Collateral Materials: All product communication materials (which are generated by sales and marketing, with the assistance of scientific and development research) must be approved by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) before they can be used by the company's sales force. Prior to FDA submission, these materials are circulated and approved by various departments within the company, with legal and regulatory having final authority.

To Learn More About Pharmaceutical and Biotechnical Commercialization Phase

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.